Senior Manager, Quality Assurance (GMP Operations)
Gilead SciencesUnited States - California - Foster City · full time · Senior
$157,590 – $203,940
Listed on Gilead Sciences’s own careers site. You apply with them directly — we never stand between you and the employer.
What this role is
Lead quality assurance operations for a new biologics manufacturing facility at Gilead, overseeing GMP compliance, batch release, laboratory oversight, and regulatory readiness. Suited for experienced quality professionals with deep pharma manufacturing knowledge who want to shape operations at a cutting-edge facility while managing and developing a team.
Our summary, not Gilead Sciences’s wording. The full posting is on their site.
Skills this role names
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What they ask for
Required
- 8+ years in GMP environment with BS/BA, or 6+ years with MS, or 2+ years with PhD
- Experience across broad areas of Quality Assurance and Quality Systems
- Knowledge of GMPs and GLPs
- Knowledge of QA principles, concepts, industry practices, and standards
- Excellent verbal, written, and interpersonal communication skills
- Understanding of international quality systems regulations
- Knowledge of Computer System Validation including electronic records and signature requirements
- Experience interacting with regulatory agencies
Nice to have
- Knowledge of Six Sigma and DMAIC methodology
- Knowledge of Risk Management tools such as HACCP and FMEA
- ASQ certification (Certified Quality Auditor, Certified Quality Engineer, or Certified Quality Manager) or other industry-recognized professional certifications